All proposals submitted by the Institute must be reviewed and approved by the PI’s Department Head or Lab Director and, in most cases, the Dean of the appropriate School. Moreover, each proposal using human subjects or animals requires additional approval of a new or amended protocol specific to that proposal before an award is activated.
- Use of Human Subjects – An appropriate protocol must be submitted to and approved by the Committee on the Use of Humans as Experimental Subjects (COUHES) on an annual basis for the use of humans as any type of research subject, whether biological, psychological, or sociological.
Exemption protocols also require annual review and approval.
At proposal stage, the Special Review tab should list the Protocol as “Pending.”
Note that even if the PI has an approved protocol for that body of work, the proposal or resulting award would need to be added to the list of funding sources by COUHES before the protocol can deemed to be “approved” for that particular project. If there is an existing protocol under which the PI will be requesting the resulting award be added, then the Special Review Comments section should be populated with the anticipated protocol number and most recent date of approval. The PI will need to request that this source of funding be added to the existing protocol prior to activation of the award.
Federal regulations require that all personnel involved in any NIH sponsored research take and pass a training course on human subjects research before embarking on such research. MIT policy extends this requirement to all MIT personnel involved in any human subjects research.
Additionally, MIT Policy requires all individuals participating ;in research involving human subjects (whether or not any specific individual performs research utilizing human subjects, serum or other bodily fluids extracted from humans, or data derived from humans) must successfully complete an approved human subjects training program.
All individuals receiving NIH traineeships must successfully complete an approved human subjects training program, whether or not they currently are performing research involving humans as subjects.
In the case of non-competing renewals, the training must be completed prior to OSP's submitting of the proposal to the sponsor. In the case of competing renewals and new proposals which are subject to just-in-time review, the training must be completed prior to the establishment of the research award.
- Use of Animals – An appropriate protocol for the use of laboratory animals must be submitted to and approved by the Committee on Animal Care. The Committee provides three year protocol approvals with annual renewals within the three year period.
Similarly to the instruction above, if a protocol is in existence, the Special Review tab should still mark the protocol as “Pending” at proposal stage and a notation listing the existing protocol number with most recent date of approval should be added to the Special Review Comments section.